Experimental Ebola drugs use in West Africa is ethical, says WHO

The World Health Organisation backs use of experimental Ebola drugs in West
Africa outbreak

A man has his temperature taken using an infrared digital laser thermometer at the Nnamdi Azikiwe International Airport in Abuja. Nigeria's commercial capital Lagos has 10 confirmed cases of Ebola, up from seven at the last count, and two patients have died.Photo: REUTERS/Afolabi Sotunde

By Rebecca Smith, Medical Editor

11:45AM BST 12 Aug 2014

Untested medicines and vaccines should be used to treat Ebola patients, the World Health Organisation has said, as the drugs could be 'potential asset' it was argued.

Experts have warned that using human Ebola victims for experiments was not ethical but after convening a panel of ethicists the WHO has agreed that untested drugs should be used.

Others have said it was unethical to withhold experimental treatments that could potentially help patients.

In a statement released by the WHO it stipulated that patients should give consent where possible to being treated with the drugs and all aspects of their care be transparent.

The panel was convened after an experimental drug called, ZMapp, made by American biotech company Mapp Biopharmaceutical, was given to two American health workers infected with Ebola in Liberia.

An elderly Spanish priest who was being treated with the drug became the first European to die from Ebola.

He died on Tuesday succumbing to the virus in a Madrid hospital five days after being evacuated from Liberia.

The 75-year-old Roman Catholic priest, Miguel Pajares, was being treated in Spain after being flown to Madrid on August 7 - the first patient to be evacuated to Europe in the fast-spreading African outbreak.

He contracted Ebola at the Saint Joseph Hospital in the Liberian capital Monrovia where he worked with patients suffering from the disease.

Two American health care workers are also being treated with ZMapp while other untested medicines are being made available.

The death toll has now reached 1,013 with the largest number of reported new deaths in Liberia, where 29 people died, followed by 17 in Sierra Leone and six in Guinea.

Prof Tom Solomon, director of the Health Protection Research Unit in Emerging and Zoonotic Infections, and director of the Institute of Infection and Global Health, University of Liverpool, said: "Doctors often use drugs on a compassionate basis, to treat medical conditions for which the drugs have not been evaluated.

“However the difference here is that some of these new treatments have not been evaluated at all. For all new drugs there is always a “first in man” study, where the drug is given to a human for the first time.

“The difference here is the desire for this “first in man” experiment to be for a patient with the disease. What is key is that if these new experimental drugs are going to be used, then this should only be done in the context of a clinical trial.

Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said: "Giving unlicensed and untested (at least in humans) treatments and vaccines is a very thorny ethical issue.

"The infected US healthcare workers are receiving a type of treatment (antibodies that specifically target the virus) that has a reasonably long safety track record, so it isn't surprising - given the high fatality rate in the current outbreak - that they are happy to receive the therapy.

"But not all drugs are safe - that's why we have very stringent clinical trials. One could argue that the current outbreak provides a perfect arena in which to test new drugs, but that isn't without risk.

“We don't know their safety, we don't know if they are likely to work - sure they have been tested in animals but these studies don't always tell us what will happen in humans.

"Also, who do you give the drugs to - infected people from the general populace, or healthcare workers battling in the frontline? Restricting treatment only to healthcare workers and volunteers could be seen as unethical, but treating the larger number of local infected people isn't easy; the supply isn't large enough and trying untested treatments that may or may not work and may or may not be safe might reverse all the efforts made building trust and goodwill.

"At the end of the day, good infection control is what is going to beat this virus."

Prof Paul Hunter, Professor of Health Protection, University of East Anglia, said: "Given the likely outcome in most patients with infection without specific therapy, I think that most doctors would want to try such therapies for their patients and for themselves if infected.

“The current system of ethical review of trials of medical interventions have made substantial contributions to protection patients from potentially ineffective or harmful treatments. However, it would be intolerable if this system was so inflexible that it contributed to the deaths of patients who could be saved.

"In my view the ethical case is unequivocal. If a patient is likely to die and an experimental therapy has a reasonable chance to prevent death then it should be given. However, this does not mean that any old drug could be given.

“For an experimental compound to be given there should be good prior evidence that the therapy will work, the patient or his relatives should give informed consent wherever possible and whenever the therapy is given proper records must be kept and the outcome reported to WHO.

“Ideally the WHO should produce a list as soon as possible of experimental drugs/therapies where there is sufficient evidence for them to be considered."

The WHO statement added: "Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control," the panel said in a statement.

"However, a specific treatment or vaccine would be a potent asset to counter the virus."